Effects of Probiotics on the Gut Microbiome of Infants Treated With Antibiotics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change from birth,7 days,14 days(or 21 days) on gut mcrobiome at 42 days
研究概览
简要总结
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants treated with antibiotics.
详细描述
This study aims to examin the impact of probiotics under 2 separate conditions, probiotics concurrent administration with antibiotic and probiotics administration during the recovery phase.Birth,7 days,14 days(or 21 days) and 42 days data will be collected and put into analysis to provide somes suggestions on the probiotics use in the clinical for the infants treated with antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with infectious diseases treated with antibiotic
排除标准
- •Gestational weeks <37
- •Birth weight <2500g or ≥4000g
- •History of asphyxia anoxia at birth
- •With congenital metabolic diseases or hereditary diseases
- •With gastrointestinal diseases
研究组 & 干预措施
antibiotics
the patients in this arm will not receive probiotics.
probiotics concurrent with antibiotic
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks concurrent with antibiotic.
干预措施: Probiotics (Dietary Supplement)
probiotics after antibiotic
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks after antibiotic.
干预措施: Probiotics (Dietary Supplement)
结局指标
主要结局
change from birth,7 days,14 days(or 21 days) on gut mcrobiome at 42 days
时间窗: 42 days
change of the gut mcrobiome will be calculated at 42 days in comparison with birth,7 days,14 days(or 21 days)
次要结局
- change from birth on gut mcrobiome at 7 days(7 days)
- change from birth and 7 days on gut mcrobiome at 14 days(or 21 days)(14 days（or 21days）)
研究者
Huanlong Qin
Director
Shanghai 10th People's Hospital